SCAR AID SCMP-1

GUDID 00854763005600

Scar Aid Mastopexy L/R 12.6" x 3.8"

BIODERMIS CORPORATION

Scar management dressing, reusable
Primary Device ID00854763005600
NIH Device Record Keyb66350f1-29b4-4445-bba8-190ae1b0f2c4
Commercial Distribution StatusIn Commercial Distribution
Brand NameSCAR AID
Version Model NumberSCMP-1
Catalog NumberSCMP-1
Company DUNS809650005
Company NameBIODERMIS CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone702-260-4466
Emailcustomerservice@scaraid.com
Phone702-260-4466
Emailcustomerservice@scaraid.com
Phone702-260-4466
Emailcustomerservice@scaraid.com
Phone702-260-4466
Emailcustomerservice@scaraid.com
Phone702-260-4466
Emailcustomerservice@scaraid.com
Phone702-260-4466
Emailcustomerservice@scaraid.com
Phone702-260-4466
Emailcustomerservice@scaraid.com
Phone702-260-4466
Emailcustomerservice@scaraid.com
Phone702-260-4466
Emailcustomerservice@scaraid.com
Phone702-260-4466
Emailcustomerservice@scaraid.com
Phone702-260-4466
Emailcustomerservice@scaraid.com
Phone702-260-4466
Emailcustomerservice@scaraid.com
Phone702-260-4466
Emailcustomerservice@scaraid.com
Phone702-260-4466
Emailcustomerservice@scaraid.com
Phone702-260-4466
Emailcustomerservice@scaraid.com
Phone702-260-4466
Emailcustomerservice@scaraid.com
Phone702-260-4466
Emailcustomerservice@scaraid.com
Phone702-260-4466
Emailcustomerservice@scaraid.com
Phone702-260-4466
Emailcustomerservice@scaraid.com
Phone702-260-4466
Emailcustomerservice@scaraid.com
Phone702-260-4466
Emailcustomerservice@scaraid.com
Phone702-260-4466
Emailcustomerservice@scaraid.com
Phone702-260-4466
Emailcustomerservice@scaraid.com
Phone702-260-4466
Emailcustomerservice@scaraid.com
Phone702-260-4466
Emailcustomerservice@scaraid.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100854763005600 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MDAElastomer, Silicone, For Scar Management

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-04
Device Publish Date2020-08-27

On-Brand Devices [SCAR AID]

00854763005976Scar Aid Fabric 6 Up, 30 Sheets 2.75" x 1.18",
00854763005969Scar Aid Fabric, 3 Up, 15 Pack 2.75" x 1.18"
00854763005945Scar Aid SPF 15 Silicone Stick, 17g
00854763005938Scar Aid SPF 15 Silicone Stick, 4.25g
00854763005921Scar Aid Kids Silicone Stick, 17g
00854763005914Scar Aid Kids Silicone Stick, 4.25g
00854763005907Scar Aid Silicone Stick, 17g
00854763005891Scar Aid Stick, 4.25g
00854763005884Scar Aid Ointment Tube 10g
00854763005747Scar Aid EpiTab Squares 30-Pack 1.25" x 1.25"
00854763005730Scar Aid EpiTab Circles 30-Pack 1.90 cm Diam.
00854763005723Scar Aid EpiTab Squares 6-Pack 1.25" x 1.25"
00854763005716Scar Aid EpiTab Circles 6-Pack 1.90 cm Diam.
00854763005709Scar Aid Areopexy 2.75" OD x .75 ID x 5.90" L, 5 Pair
00854763005693Scar Aid Areopexy 2.75" OD x .75 ID x 5.90" L
00854763005686Scar Aid C-Strip 1.4" x 6.0"
00854763005679Scar Aid C-Strip 1.4" x 6.0", 5 Pack
00854763005662Scar Aid Areola Circles 3" x 0.75", 5 Pack
00854763005655Scar Aid Mastopexy-L/R 12.6" x 3.8"
00854763005648Scar Aid Large 11" x 15.75", 5 Pack.
00854763005631Scar Aid Strip 1.4" x 11.5", 5 Pack
00854763005624Scar Aid Patch 2" x 2.5", 5 Pack
00854763005617Scar Aid Areola Circles 3" x 0.75", 1 Pair
00854763005600Scar Aid Mastopexy L/R 12.6" x 3.8"
00854763005594Scar Aid Large Sheet 11" x 15.75"
00854763005587Scar Aid Strip 1.4" x 11.5"
00854763005570Scar Aid Patch 2" x 2.5"
00854763005563Scar Aid Standard sheet 4.7" x 5.7"
00854763005556Scar Aid Standard sheet 4.7" x 5.7", 5 Pack
00854763005266Scar Aid Fabric C-Strip 1.4" x 6.0", 5 Strips
00854763005259Scar Aid Fabric C-Strip 1.4" x 6.0", 1 Strip
00854763005204Scar Aid Fabric, 6 Up Sheets 2.75" x 1.18", 6 sheets per box.
00854763005198Scar Aid Fabric, 3 Up Sheets 2.75" x 1.18", 3 sheets per box.
00854763005181Scar Aid Fabric Mastopexy-L/R 12.6" x 3.8", 5 Pair
00854763005174Scar Aid Fabric Mastopexy-L/R 12.6" x 3.8", 1 pair
00854763005167Scar Aid Fabric Areopexy 2.75" OD x .75 ID x 5.90" L (6.9cm OD x 1.9cm ID) 5 pair
00854763005150Scar Aid Fabric Areopexy 2.75" OD x .75 ID x 5.90" L (6.9cm OD x 1.9cm ID) 1 pair
00854763005143Scar Aid Fabric Areola Circles, 3" x 0.75", 5 Pair
00854763005136Scar Aid Fabric Areola Circles 3" x 0.75", 1 Pair
00854763005129Scar Aid Fabric EpiTab Squares 30-Pack 1.25" x 1.25"
00854763005112Scar Aid Fabric EpiTab Squares 6-Pack 1.25" x 1.25"
00854763005105Scar Aid Fabric EpiTab Circles 30-Pack 1.90 cm Diam.
00854763005099Scar Aid Fabric EpiTab Circles 6-Pack 1.90 cm Diam.
00854763005082Scar Aid Fabric Patch 2" x 2.5", 5 Pair
00854763005075Scar Aid Fabric Patch 2" x 2.5", 1 Pair
00854763005068Scar Aid Fabric Strip 1.4" x 11.5", 5 Pair
00854763005051Scar Aid Fabric Strip 1.4" x 11.5", 1 Pair
00854763005044Scar Aid Fabric Large Sheet 11" x 15.25", 5 Pack
00854763005037Scar Aid Fabric Large Sheet 11" x 15.25"
00854763005020Scar Aid Fabric Standard sheet 4.7" x 5.7", 5 Pack
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